Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040119
Company: PAI HOLDINGS

• REMS

Products on ANDA 040119

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040119

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/1996	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/31/2024	SUPPL-22	REMS - MODIFIED - D-N-A		Label is not available on this site.
02/08/2024	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/08/2024	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/07/2019	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/20/2018	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-13	REMS - PROPOSAL - D-N-A		Label is not available on this site.
01/29/2018	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
08/29/2017	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/29/2017	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
12/16/2016	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/22/2013	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
05/16/2013	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/12/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/23/2011	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/30/2007	SUPPL-2	Labeling		Label is not available on this site.
09/12/2007	SUPPL-1	Labeling		Label is not available on this site.